Brexucabtagene autoleucel
Brexucabtagene autoleucel (Tecartus, Kite Pharma EU B.V.) has 2 EU-approved indications in 2 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Acute lymphoblastic leukaemia1 | |||
None | Monotherapy | 2L | B-cell precursor ALL only; 26 years of age and above |
| Mantle cell lymphoma1 | |||
None | Monotherapy | 3L+ | After two or more lines of systemic therapy including a BTK inhibitor |
Full text of section 4.1 (therapeutic indications)
Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
Label history
21 changes to the Tecartus label since 2022, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes